On Monday, RFK Jr. and FDA Commissioner Dr. Martin Makary made an announcement that black box safety warnings would be removed from hormone drugs for women that treat the symptoms of menopause.
The FDA had placed warnings on all hormone therapy creams, pills and other treatments that said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes.
There are millions of women for whom HRT is contraindicated—such as those with a previous history of blood clots or stroke, certain blood conditions, and many of those with a history of breast cancer.
“We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,” Makary said in a news conference. “The FDA is taking action to remove the black box warnings from estrogen-related products. This is based on a robust review of the latest scientific evidence.”
Makary has made some weird claims that overstated both the negative affects of menopause, as well as the science on HRT.
While Makary claimed that “HRT has saved marriages, rescued women from depression, prevented children from going without a mother,” other experts disagreed.
- While Dr. Kelly Casperson, a urologist and “expert and advocate for sexuality and hormones,” warned that “families fracture” if women don’t get treated for the symptoms of menopause, Makary went a step further to say menopause can cause divorce — not just mood swings and hot flashes.
- Makary is also suggesting that doctors test the hormone levels of perimenopausal patients “to figure out when is the right time to start.” However, the North American Menopause Society explicitly recommends against testing for estrogen levels in perimenopausal women because they fluctuate so much throughout a woman’s cycle. Instead, doctors should prescribe estrogen based on a woman’s symptoms.
“For the first time in a generation, the FDA is standing with science and standing with women.”
Except when they’re not.
The Trump FDA has added warnings to medications long deemed safe, including adding a black box warning for pregnant women taking SSRI antidepressants, concluded by a male majority panel.
They also announced in September a review of mifepristone, an abortion medication, despite more than 100 scientific studies deeming it safe and effective.